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NOT YET RECRUITING
NCT06375928
NA

EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial)

Sponsor: Hospital Universitari de Bellvitge

View on ClinicalTrials.gov

Summary

The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and surgery in patients with resectable distal malignant biliary obstruction.

Official title: Endoscopic Ultrasound-Guided Biliary Drainage With Lumen-Apposing Stent vs Classical ERCP for First-line Therapy of Malignant Distal Biliary Obstruction in Resectable Disease: An Open-label, Multicenter Randomized Controlled Trial (CARPEDIEM-1 Trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2024-05-01

Completion Date

2026-05-01

Last Updated

2024-04-19

Healthy Volunteers

No

Interventions

PROCEDURE

Endoscopic biliary drainage

Decompression of the bile duct by endoscopic aproach.

DEVICE

Self-expandable metallic stent (SEMS)

Self-expandable metallic stent (SEMS) deployment: * Covering: Uncovered or Partially Covered. Non covered if gallbladder is present. * Size: 10x40mm or 10x60mm or 10x80mm.

DEVICE

Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)

Lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPPS) deployment: * LAMS size: 6x8mm or 8x8mm. Consider 10x10mm if bile duct \> 18mm. * DPPS size: 7Fr x 3-7cm.

Locations (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain